Presentation delivered by Sonia Sethi, Vice President, Clinical Operations & Client Engagement, Veristat and Jacqueline Mardell, Vice President, Clinical Operations, Ascendis Pharma at the marcus evans Evolution Summit Fall 2019 in San Diego CA

1. EVOLUTION SUMMIT FALL 2019 | THURSDAY, SEPT 12, 2019
Sonia Sethi
Vice President, Clinical Operations
Jacqueline Mardell,
Vice President Clinical Operations
Turning Sponsor/CRO Relationships
into Partnerships for Success

2. ASCENDISPHARMA.COM | VERISTAT.COM2
THE LATEST IN A CONTINUING SERIES
Rescue CRO: Thoughts for Taking the Ultimate Step to Save the Study October 27 2017
It’s Not Me, It’s You: When Sponsor/Vendor Relationships go off the Rails
February 10 2017
Vendor Qualification: A Strategy for Building Stronger Vendor-Sponsor Relationships
March 15 2016
Best Practices for Conducting Multi-Regional Trials in Emerging Regions
January 12 2016
Source: http://www.clinicaltrialsarena.com/archive/

3. ASCENDISPHARMA.COM | VERISTAT.COM3
THE PARTNERSHIP PROBLEM
Missed
timelinesResourcing
issues
Mistrust
or fear
Performance
problems
Dissatisfied!

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THE RFP PROCESS IS TRANSACTIONAL AND TIME-CONSUMING
RFP
Defense
Contract/
WO
Conduct
Evaluate

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LOOP OF DOOM
“We can’t stop behaving
like a vendor until you
stop treating us like one”
“We can’t stop treating
you like a vendor until you
stop behaving like one”

6. Expand our thinking beyond the
transactional
ASCENDISPHARMA.COM | VERISTAT.COM6
CASE FOR STRATEGIC
PARTNERSHIP

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CHALLENGES OF PARTNERSHIPS BETWEEN SPONSOR AND CRO
Fundamentally different business models
Risk asymmetry
Each party may have multiple strategic partnerships, creating competition
Supplier complacency
Opportunistic behavior by either party
Unrealistic expectations
That either side will repeatedly sacrifice its own interests for the good of its partner
That everything will be perfect from now on

8.  More than “full-service model”
 Includes “soft” factors,
 High degree of mutual trust and respect
 A “formal” business arrangement
codified in written agreements with
metrics
 Also includes attitudes, mindset, and
behaviors of individuals at the “partner”
companies.
 Sponsor treats individuals at the CRO as
extended team members.
 When (not if) problems occur, both sides
sit down to engage in root-cause
diagnosis and correction.
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CHARACTERISTICS OF
PARTNERSHIPS

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MISALIGNMENT OF GOALS & OBJECTIVES BETWEEN SPONSOR
AND CRO AND POOR INFORMATION SHARING

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DIFFERENT FROM A TRANSACTIONAL SERVICE RELATIONSHIP
Needs to last long enough to motivate investment (of time, effort, and/or capital) by
partners
drive continuous improvement and innovation
Close integration of planning and operations between partners
Information sharing
extensive integration of processes
coordinated decision-making
Significant investment in joint planning to minimize or mitigate risks to both sides
Define how each side will benefit, and what each sides needs to commit and and invest
to ensure success

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STRATEGIC PARTNERSHIPS REQUIRE
High degree of TRUST
between partners
Tolerance for failure
Individual and organizational
competencies for managing
differences between partners,
and for managing inevitable
disagreement and conflict.
Robust governance structures
and mechanisms across multiple
functions and levels
Building and maintaining alignment
within each organization may be greater
than doing so with the partner.
Agreement language that
recognizes maximization of long-
term value over short-term gains
CROs view guaranteed revenue streams in
exchange for long-term commitments
(resourcing) more positively than penalty
language

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AMONG SPONSORS WHO REPORT…
Faster, cost-
effective studies
Share
development
plans
Slower, more
expensive studies
Do not share
information
67%
42%

13. Joint Business Plans
 Multi year
 Common goals
 What each partner hopes to achieve
through the partnership
 Risks/barriers with mitigation plan
 Commitments and investments made by
each partner
ASCENDISPHARMA.COM | VERISTAT.COM13
SUCCESS FACTORS

14. MORE SUCCESS FACTORS
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Multi-Level Governance
 Identify and frame important decisions
 Right people make the right decisions
using the right information
 Accountability for implementation
 Clear escalation pathway
 Lessons learned shared across all studies,
therapeutic areas

15. How work will be done (Work
Instructions, roles and responsibilities)
Common vocabulary
 Collaborative problem solving
 Joint decision making
 Conflict management
 Change management
CRO staff - Shift from executing tasks to
delivering results
Sponsor staff – shift from micromanaging
to collaborative oversight
ASCENDISPHARMA.COM | VERISTAT.COM15
JOINT TRAINING

16. CROs can give feedback to sponsor
Operational and strategic KPIs, leading
and lagging indicators
 Lagging – audit findings, cost variance,
change orders
 Leading – progress against upcoming
milestones, level of trust between
partners
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MEASURE WITH A TWO-
WAY SCORECARD

17. HOW DO I FIND A SUITABLE PARTNER?
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Size and fit matter
Alignment of values between
parties matters
Relationships take time

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SPONSORS MAY REQUIRE ONE OR BOTH
DRUG
DEVELOPMENT/THERAPEUTIC
EXPERTISE
FLAWLESS
EXECUTION

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IS STRATEGIC PARTNERSHIP
THE ONLY WAY?
 Of course not
 Single study, transactional or peak
activity resource engagement is fine
 As long as expectations are clear on
both sides

20.  Differences are acknowledged and
jointly managed
 “We are all colleagues”
 Sponsors provide high degree of
transparency regarding development
plans
 Policies, process and procedures and
aligned and integrated so the team can
function smoothly as one
 Clear roles and responsibilities
 Potential problems are identified early
in an atmosphere of trust. Root cause
analysis and solutions are done together
ASCENDISPHARMA.COM | VERISTAT.COM20
CHARACTERISTICS OF THE
MOST SUCCESSFUL
PARTNERSHIPS

21.  Unclear or unrealistic expectations on one or
both sides
 “You work for us; we don’t work for you.”
 Sponsor provides limited visibility into
development plans
 Lack of clarity around roles, responsibilities,
process and procedures
 Sponsor either micro-manages or silos the
CRO
 Problems are hidden from the other party
until it becomes difficult to solve without
significant detriment to the study
 Blaming and shaming
ASCENDISPHARMA.COM | VERISTAT.COM21
CHARACTERISTICS OF THE
LEAST SUCCESSFUL
PARTNERSHIPS

22. SUMMARY
ASCENDISPHARMA.COM | VERISTAT.COM22
 Performance problems, high staff turnover, lack of team cohesion
may be related to sponsor/CRO relationship problems
 It takes a lot of early work and planning to create a sustainable
partnership that works for both sides but the work pays dividends
 Sponsors and CROs who invest in strategic partnerships often
report faster, more cost-effectively run studies
 Building the relationship takes time. Don’t try shortcuts.

23. Sonia Sethi
Vice President, Clinical Operations
sonia.sethi@veristat.com
Jacqueline Mardell,
Vice President Clinical Operations
jwm@AscendisPharma.com
Thank You! Any Questions?